BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 8113716 · Received November 28, 2018

    Report

    Report Number
    1628664-2018-02074
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 7, 2018
    Report Date
    January 21, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE ABBOTT FIELD SERVICE ENGINEER (FSE) DURING A SUBSEQUENT SITE VISIT PERFORMED VARIOUS VERIFICATION PROCEDURES AND DETERMINED THE VALVE, MANIFOLD KIT (ROHS) PART NUMBER 7-77612-03 WAS NOT PERFORMING EFFECTIVELY. THE VALVE, MANIFOLD KIT (ROHS) WAS REPLACED BY THE FSE AND THE CUSTOMER REPLACED THE ARC PROBE (LIST NUMBER 08C94-42). THERE WERE NO ADDITIONAL DISCREPANT RESULTS REPORTED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF INSTRUMENT SERVICE HISTORY FOR THE ARCHITECT, SERIAL NUMBER I1SR02018, VERIFIES NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. THE ARCHITECT SYSTEM OPERATIONS MANUAL CONTAINS ADEQUATE INFORMATION FOR TROUBLESHOOTING THE OBSERVED ISSUE. THE ARCHITECT I1000SR SERVICE AND SUPPORT MANUAL CONTAINS ADEQUATE INFORMATION FOR THE TROUBLESHOOTING, REMOVAL, AND REPLACEMENT OF THE VALVE, MANIFOLD KIT (ROHS) AND THE ARC PROBE. THERE WERE NO SIMILAR COMPLAINTS OR TRENDS IDENTIFIED FOR THE ANALYZER, THE VALVE, MANIFOLD KIT (ROHS), OR THE ARC PROBE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT I1SR02018, THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-03, OR THE ARC PROBE (LIST NUMBER 08C94-42).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY NEGATIVE TROPONIN-I RESULT WHILE USING THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED. SID: (B)(6) (TESTED (B)(6) 2018 AT 07:26) LESS THAN 2.0 PG/ML (NEGATIVE). PREVIOUS AND SUBSEQUENT RESULTS FOR THE SAME PATIENT WERE POSITIVE. SID: (B)(6) (TESTED (B)(6) 2018 AT 11:27) 540 PG/ML (POSITIVE). SID: (B)(6) (TESTED (B)(6) 2018 19:32) 1400 PG/ML (POSITIVE). SID: (B)(6) (TESTED (B)(6) 2018 13:38) 514 PG/ML (POSITIVE). SID: (B)(6) (TESTED (B)(6) 2018 12:45) 589 PG/ML (POSITIVE). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952873 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740001544

    Patients

    Seq Age Sex Outcome Treatment
    1